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news.Barrier Therapeutics has reported positive results for a key safety and dose escalation study with its novel oral antifungal agent, pramiconazole.
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No clinically relevant changes were seen in any of the 32 healthy volunteers dosed with up to six grams of pramiconazole given over a five-day period, as compared to placebo.
The study measured cardiac parameters, including QT/QTc interval, liver and kidney function and several other blood chemistry parameters. The total of six grams administered over five days is 30 times higher than the single weekly dose of 200mg of pramiconazole that is being used in a Phase IIa study in toenail onychomycosis (nail fungus) currently underway in Europe.
Braham Shroot, chief scientific officer of Barrier, said: “In this placebo-controlled, dose escalation, safety study, healthy volunteers who received high doses of pramiconazole showed no clinically relevant changes in any of the key safety parameters. When we consider these data along with previously reported clinical efficacy results in onychomycosis and other fungal infections, we continue to believe there is a strong clinical rationale for advancing this product candidate to the next stage of development.”